BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4183569 · Received October 18, 2014

    Report

    Report Number
    2032227-2014-40364
    Event Type
    Malfunction
    Date Received
    October 18, 2014
    Date of Event
    September 20, 2014
    Report Date
    September 20, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTED 1 OPENED/USED ENLITE SENSOR AND PERFORMED BICARBONATE BUFFER TEST. SENSOR PASSED PER SPECIFICATION WITH ACCURATE READINGS.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING CALIBRATION ERROR ALARMS AND SENSOR END ALARMS ON HER INSULIN PUMP. SHE ALSO STATED HER INSULIN PUMP HAD GONE INTO THRESHOLD SUSPEND. THE CUSTOMER'S BLOOD GLUCOSE WAS 131 MG/DL. TROUBLESHOOTING FOR THE CALIBRATION ERROR ALERTS FOUND THE CUSTOMER WAS USING THE PROPER TECHNIQUE FOR CALIBRATION. THE CUSTOMER WAS ADVISED HER SENSOR MAY BE MALFUNCTIONING. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663879 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A G284U

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR